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Autoinjector Prefilled Syringe

Taltz autoinjector and prefilled syringe

Taltz provides additional support to help you feel comfortable and confident using our autoinjector or prefilled syringe. In fact, over 94% of adult patients agreed the Taltz autoinjector was “easy to use” and were confident in their ability to use it.*

*Please see Instructions for Use included with the device.

If you’re seeking injection training, then great news! We have training options available for you.

Contact Taltz Together at 1-844-TALTZ-NOW (1-844-825-8966)

recommended areas to inject Taltz

When taking Taltz, please remember

  • Take your device out of the refrigerator and let it sit for 30 minutes to warm to room temperature. Leave the base cap/cap on the device while it is warming up to room temperature
  • You may inject the medicine into your stomach (abdomen) or thigh
  • Another person may give you the injection in the back of your arm
  • Alternate your injection site. Do not inject in the exact same spot every time
  • Do not inject within 1 inch of your belly button
  • Do not give an injection into areas where the skin is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis

One of the most common side effects of Taltz is injection site reactions. However, most injection site reactions were mild to moderate and didn’t stop people from taking Taltz.

Before you or your caregiver inject for the first time, your healthcare provider should show you or your caregiver how to prepare and inject Taltz.

TODO

Important storage information

do not use Taltz if frozen

Do not use Taltz if it has been frozen.

protect Taltz from light

You should protect Taltz from light at all times.

do not shake Taltz

Do not shake your Taltz device.

do not use Taltz if frozen

Do not use Taltz if it has been frozen.

protect Taltz from light

You should protect Taltz from light at all times.

do not shake Taltz

Do not shake your Taltz device.

Helpful injection tips

Talk to your doctor about whether the tips below may help with the injection of biologics.*

  • Placing something cold (such as an ice gel pack or cold water bottle) on the injection site before and after the injection may help reduce pain
  • Acetaminophen may help relieve pain
  • Antihistamines or topical corticosteroids may help with itching or swelling caused by the injection
  • Choose different injection sites each time you inject

The recommended places for injection are your stomach (abdomen) or thigh, and another person may give you the injection in the back of your arm.

*These tips have not been developed or studied specifically for Taltz.

Tips specific to Taltz

  • You should take Taltz out of the refrigerator and let it sit for 30 minutes to warm to room temperature before injecting. Leave the cap on the device while it is warming up to room temperature
  • If needed, patients/caregivers may store TALTZ at room temperature up to 30°C (86°F) for up to 5 days in the original carton to protect from light if carton contains 1 prefilled syringe. Once Taltz has been stored at room temperature, do not return to refrigerator and discard if unused, within 5 days
  • However, Taltz should not be microwaved, run under hot water, or left in direct sunlight
  • There are 2 devices available for injecting Taltz: an autoinjector and a prefilled syringe

Select Important Safety Information

Taltz affects the immune system. It may increase your risk of infections. Some people have had serious infections, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized from these infections. Do not use Taltz if you have any symptoms of infection, unless your doctor tells you to. If you have a symptom after starting Taltz, call your doctor right away.

Things to know

You may experience side effects while taking Taltz. If you do, please reach out to your doctor.

Injection site reactions

  • Injection site pain may occur while you are injecting. Other reactions, such as redness, may happen after several days
  • Most injection site reactions were mild to moderate and did not stop people from taking Taltz
  • Talk to your doctor about any injection site reactions

If you are experiencing injection site reactions with one type of device, talk to your doctor about whether it might be appropriate to switch to the other Taltz device.

The other most common side effects include:

  • Upper respiratory infections
  • Fungal skin infections
  • Nausea

These are not all of the possible side effects of Taltz. Serious side effects may occur. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

Lilly is currently monitoring and will continue to monitor and communicate additional information about injection site reactions. Please contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) if you have more questions about this topic.

1. Callis Duffin K, Bagel J, Bukhalo M, et al. Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER‐A). J Eur Acad Dermatol Venereol. 2017;31:107-113. 2. Data on file. Lilly, USA, LLC. DOF-IX-US-0345.

SAFETY SUMMARY

Warnings -

Taltz affects the immune system. It may increase your risk of infections, some people have had serious infections, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized from these infections. Do not use Taltz if you have any symptoms of infection, unless your doctor tells you to. If you have a symptom after starting Taltz, call your doctor right away.

Your doctor should check you for TB before you start Taltz, and watch you closely for signs of TB during and after treatment with Taltz. If you have TB, or had it in the past, your doctor may treat you for it before you start Taltz.

Do not use Taltz if you have had a serious allergic reaction to ixekizumab or any other ingredient in Taltz, such as: swelling of your eyelids, lips, mouth, tongue or throat, trouble breathing, feeling faint, throat or chest tightness, or skin rash. Get emergency help right away if you have any of these reactions. See the Medication Guide that comes with Taltz for a list of ingredients.

Severe skin reactions that look like eczema can happen during treatment with Taltz from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with Taltz if you develop severe skin reactions. Tell your doctor if you have any of the following: redness or rash, itching, patches, your skin is dry or feels like leather, blisters or abrasions that ooze or become crusty, small bumps or plaques with scale or crusting.

Crohn’s disease or ulcerative colitis (inflammatory bowel disease) can start or get worse with Taltz use. Tell your doctor if you have any of these symptoms or if they get worse: stomach pain, diarrhea, and weight loss.

You should not get live vaccines while taking Taltz. You should get the vaccines you need before you start Taltz.

Common side effects
The most common side effects of Taltz include:

  • Injection site reactions
  • Nausea
  • Upper respiratory infections
  • Fungal skin infections

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Before you use Taltz, review these questions with your doctor:

❑ Are you being treated for an infection?
❑ Do you have an infection that does not go away or keeps coming back?
❑ Do you have TB or have you been in close contact with someone with TB?
❑ Do you have possible symptoms of an infection such as fever, cough, sores, diarrhea, or other symptoms? Ask your doctor about other possible symptoms.
❑ Do you have Crohn’s disease or ulcerative colitis?

Tell your doctor if:

❑ You need any vaccines or have had one recently.
❑ You take prescription or over-the-counter medicines, vitamins, or herbal supplements.
❑ You are pregnant or planning to become pregnant. It is not known if Taltz can harm an unborn baby. Pregnancy Exposure Registry: There is a pregnancy registry to collect information about women who are exposed to Taltz during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become pregnant while taking Taltz, you are encouraged to enroll in the pregnancy registry by calling 1-800-284-1695 or by visiting online at http://www.pregnancyregistry.lilly.com.
❑ You are breastfeeding or planning to breastfeed. It is not known if Taltz passes into breastmilk.

How to take

See the instructions for use that come with Taltz. There you will find information about how to store, prepare, and inject Taltz. Adults may self-inject after receiving training from a healthcare provider.

For children 6 to 17 years of age:

  • If your child’s healthcare provider decides that you may give Taltz injections at home, you should receive training on the right way to prepare and inject Taltz. Do not try to give Taltz to your child until you have been shown how to inject Taltz. Children should not inject themselves with Taltz. You or an adult caregiver should prepare and give Taltz injections to your child.

Learn more

Taltz is a prescription medicine available as a 80 mg/mL, 40 mg/0.5mL, 20 mg/0.25mL injection. For more information, call 1-800-545-5979 or go to taltz.lilly.com .

This summary provides basic information about Taltz but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Taltz and how to take it. Your doctor is the best person to help you decide if Taltz is right for you.

IX CON BS 20AUG2024

Taltz® and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

INDICATIONS

Taltz® (tȯl-ts) is an injectable medicine used to treat:

  • People 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
  • Adults with active psoriatic arthritis.
  • Adults with active ankylosing spondylitis.
  • Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

It is not known if Taltz is safe and effective in children for conditions other than plaque psoriasis or in children under 6 years of age.